(38 days)
No
The device description focuses on thermal ligation and cutting controlled by the surgeon via a finger switch and Hi/Low heating modes. There is no mention of AI, ML, or any form of automated decision-making or data processing that would indicate the use of these technologies.
Yes
The device is described as providing "thermal ligation and division" for "simultaneous cutting and cauterization of soft tissue during surgery," which are direct therapeutic actions on the body.
No
The device is described as "simultaneous cutting and cauterization of soft tissue during surgery," and "provides thermal ligation and division," indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical hardware components including a reusable handpiece, disposable kit (tip and power cable), and a universal power supply. It describes mechanical actions (cutting, grasping, spreading) and thermal functions (heating elements for cutting and cauterization), all of which are hardware-driven. There is no mention of software being the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "simultaneous cutting and cauterization of soft tissue during surgery, and cutting of natural or synthetic, nonmetallic sutures during surgery." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a surgical instrument with heating elements for cutting and cauterization. It's used for "thermal ligation and division in various surgical procedures."
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is clearly a surgical instrument used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MiSeal Reposable Thermal Ligating Shears are intended for the simultaneous cutting and cauterization of soft tissue during surgery, and cutting of natural or synthetic, nonmetallic sutures during surgery.
Product codes
GEI
Device Description
The MiScal Reposable Thermal Ligating Shears system consists of the following:
MiScal Reusable Handpiece
MiScal Thermal Ligating Shears Kit
Universal Power Supply 200-006R
The MiSeal Reposable Thermal Ligating Shears are designed to provide thermal ligation and division in various surgical procedures. The MiSeal Reposable Thermal Ligating Shears consist of a reusable handpiece with a heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The MiSeal Reposable Thermal Ligating Shears are designed to allow the surgeon control of the heating clement power of the device in order to accommodate the individual patient anatomy. An instrument cord connects the handpiece to the dedicated Microline Surgical Universal Power Supply K070871.
The MiSeal Reposable Handpiece is supplied non-sterile in a foam cavity placed in a fiberboard carton and is for multiple patient uses following cleaning and steam sterilization procedures performed per the provided Instructions for Use. The handpiece can be used multiple times if cleaning and sterilization procedures are followed. The MiSeal Disposable Kit (the functional instrument Tip and power cable portion of the applied part of the system) is supplied sterile in a die-cut chipboard Packaging Insert and 'I'yvek/Mylar pouch and is labeled for single use only. The tip is intended to be used by a trained physician for a single patient use in open general surgery, open vascular surgery, and laparoscopic surgical procedures.
The MiSeal single use power cable is connected to the instrument handpiece and terminates at the electrical connection of the Universal Power Supply. The system power supply is supplied non-sterile for reusable use outside the sterile field.
The MiSeal device incorporates Hi and Low heating modes that are used to coagulate and cut soft tissue. The heating elements in the disposable tip are activated by a physician controlled finger switch located on the handpiece of the device. "The MiSeal device is intended to provide general purpose dissection, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.
To coagulate and cut tissue, the physician grasps the desired tissue between the jaws of the MiScal Reposable Thermal Ligating Shears and gently squeezes the thumb trigger and handpiece to close the jaws. Depressing the finger switch and squeczing the thumb trigger activates the heating clements in the distal tip. An audible low frequency tone accompanies the activation of the heating clement in the variable mode to notify the physician the power is being applied. An audible high frequency tone will accompany the activation of the heating element in High power mode. Depressing the finger switch on the top of the handle provides cither Hi or Low heating mode. Generally, a lower UPS output setting improves the scaling capabilities and lengthens the time required to divide tissue. Conversely, a higher output setting reduces the time to divide tissue and may result in decreased vessel seal integrity
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / open general surgery, open vascular surgery, and laparoscopic surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical and performance tests were performed to assure the MiSeal Reposable Thermal Ligating Shears functioned as intended and met all product specifications. Sufficient data was generated and analyzed to prove that the MiSeal Reposable Thermal Ligating Shears was substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Microline Surgical. The logo has the word "MICROLINE" in large, bold, black letters. Below that is the word "SURGICAL" in smaller, black letters. There is a symbol between the two words that looks like four leaves arranged in a circle.
800 Cummings Center, Suite 166T Beverly, MA 01915, USA Tel: 978.922.9810 Fax: 978.922.9209 Web: www.microlinesurgical.com
KI22046 510(k) Summary
Page 1 of 3
| Contact Person: | Dean Ciporkin, Sr. Director of Regulatory Affairs and Quality Assurance |
|---|---|
| Submitted By: | Microline Surgical |
| 800 Cummings Center, | |
| Beverly, MA 01915 | |
| Tel: 978-922-9810 | |
| Fax: 978-922-9209 | |
| AUG 2 3 2012 | |
| Common Name: | Electrosurgical System |
| Device Product Code: | GEI |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories |
| 21 CFR § 787.4400 | |
| Device Panel: | General Surgery/Restorative Devices : |
| Date Prepared: | August 17, 2012 |
| Proprietary Name: | MiSeal™ Reposable Thermal Ligating Shears |
| Device Classification: | Class II |
| Predicate Device: | This product is similar in design, composition, and function to the: |
| Starion Instruments Thermal Ligating Shears (K062257) cleared October 10, 2006 | |
| Establishment Registration Number: | 1223422 |
Device description and technological Characteristics:
The MiScal Reposable Thermal Ligating Shears system consists of the following:
MiScal Reusable Handpiece
MiScal Thermal Ligating Shears Kit
Universal Power Supply 200-006R
The MiSeal Reposable Thermal Ligating Shears are designed to provide thermal ligation and division in various surgical procedures. The MiSeal Reposable Thermal Ligating Shears consist of a reusable handpiece with a
surgical procedures. The MiSeal Reposable Thermal Ligating Shears surgious proceeding the reas heating elements at the distal tip which are activated by a finger switch located on
Page 1 of 3 Confidence, simply delivered.
Image /page/0/Picture/8 description: The image contains two logos. The logo on the left is the SGS logo, which features the letters "SGS" in a stylized font. The logo on the right is the UKAS logo, which features a crown and a checkmark. Below the checkmark are the letters "UKAS" and the number "006".
1
K 122086
Page 2 of ③
the handpiece of the device. The MiSeal Reposable Thermal Ligating Shears are designed to allow the surgeon control of the heating clement power of the device in order to accommodate the individual patient anatomy. An instrument cord connects the handpiece to the dedicated Microline Surgical Universal Power Supply K070871.
The MiSeal Reposable Handpiece is supplied non-sterile in a foam cavity placed in a fiberboard carton and is for multiple patient uses following cleaning and steam sterilization procedures performed per the provided Instructions for Use. The handpiece can be used multiple times if cleaning and sterilization procedures are followed. The MiSeal Disposable Kit (the functional instrument Tip and power cable portion of the applied part of the system) is supplied sterile in a die-cut chipboard Packaging Insert and 'I'yvek/Mylar pouch and is labeled for single use only. The tip is intended to be used by a trained physician for a single patient use in open general surgery, open vascular surgery, and laparoscopic surgical procedures.
The MiSeal single use power cable is connected to the instrument handpiece and terminates at the electrical connection of the Universal Power Supply. The system power supply is supplied non-sterile for reusable use outside the sterile field.
The MiSeal device incorporates Hi and Low heating modes that are used to coagulate and cut soft tissue. The heating elements in the disposable tip are activated by a physician controlled finger switch located on the handpiece of the device. "The MiSeal device is intended to provide general purpose dissection, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.
To coagulate and cut tissue, the physician grasps the desired tissue between the jaws of the MiScal Reposable Thermal Ligating Shears and gently squeezes the thumb trigger and handpiece to close the jaws. Depressing the finger switch and squeczing the thumb trigger activates the heating clements in the distal tip. An audible low frequency tone accompanies the activation of the heating clement in the variable mode to notify the physician the power is being applied. An audible high frequency tone will accompany the activation of the heating element in High power mode. Depressing the finger switch on the top of the handle provides cither Hi or Low heating mode. Generally, a lower UPS output setting improves the scaling capabilities and lengthens the time required to divide tissue. Conversely, a higher output setting reduces the time to divide tissue and may result in decreased vessel seal integrity
Indications for Use:
The MiSeal Reposable Thermal Ligating Shears are intended for the simultaneous cutting and cauterization of soft tissue during surgery, and cutting of natural or synthetic, nonmetallic sutures during surgery.
Performance Testing:
Page 2 of 3
Confidence, simply delivered.
Image /page/1/Picture/13 description: The image contains two logos. The logo on the left is the SGS logo, which features a stylized spiral design with the letters "SGS" underneath. The logo on the right includes a crown above the letters "UNAS" and "QVS".
2
Page 3 of 3
Preclinical and performance tests were performed to assure the MiSeal Reposable Thermal Ligating Shears functioned as intended and met all product specifications. Sufficient data was generated and analyzed to prove that the MiSeal Reposable Thermal Ligating Shears was substantially equivalent to the predicate device.
Summary:
The information provided dcmonstrates that the MiSeal Reposable Thermal Ligating Shears is substantially equivalent to the Starion Instruments Thermal Ligating Shears in function, intended use and indications for use.
Image /page/2/Picture/7 description: The image shows a circular design with four leaf-like shapes arranged symmetrically around a central point. Each leaf shape is curved and pointed at the ends, resembling petals or stylized leaves. The overall design has a simple, geometric quality, and the shapes are evenly spaced within the circle.
Image /page/2/Picture/8 description: The image contains two certification logos. On the left is the SGS certification mark, featuring a stylized eye-like shape with the letters "SGS" underneath. To the right is the UKAS (United Kingdom Accreditation Service) logo, which includes a crown-like symbol above the UKAS acronym and additional text below it. The logos suggest that the product or organization associated with them has met certain standards and has been accredited by these certification bodies.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Microline Surgical % Mr. Dean Ciporkin Sr. Director of Regulatory Affairs and Quality Assurance 800 Cummings Center, Suite 166T Beverly, Massachusetts 01915
ANG 2 3 2012
Re: K122086
Trade/Device Name: MiSeal Reposable Thermal Ligating Shears Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 13, 2012 Received: July 16, 2012
Dear Mr. Ciporkin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration: Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Dean Ciporkin
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122086
Device Name: MiSeal Reposable Thermal Ligating Shears
Indications for Use:
The MiSeal Reposable Thermal Ligating Shears are intended for the simultaneous cutting and cauterization of soft tissue during surgery, and cutting of natural or synthetic, nonmetallic sutures during surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTIÑUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden mrm
Division Sign Off
sión Sign-( Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K122086